Cleared Traditional

COMPUMEDICS SOMTE PSG RECORDING SYSTEM

K072201 · Compumedics Limited · Anesthesiology
Apr 2008
Decision
250d
Days
Class 2
Risk

About This 510(k) Submission

K072201 is an FDA 510(k) clearance for the COMPUMEDICS SOMTE PSG RECORDING SYSTEM, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Compumedics Limited (Melbourne, Victoria, AU). The FDA issued a Cleared decision on April 14, 2008, 250 days after receiving the submission on August 8, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K072201 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2007
Decision Date April 14, 2008
Days to Decision 250 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375